Fluoxetine 10mg capsules

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Fluoxetine hydrochloride

Διαθέσιμο από:

DE Pharmaceuticals

Φαρμακολογική κατηγορία (ATC):

N06AB03

INN (Διεθνής Όνομα):

Fluoxetine hydrochloride

Δοσολογία:

10mg

Φαρμακοτεχνική μορφή:

Oral capsule

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04030300

Φύλλο οδηγιών χρήσης

Eight important things you need to know about Fluoxetine
capsules
• Fluoxetine treats depression and anxiety disorders. Like
all medicines it can have unwanted effects. It is therefore
important that you and your doctor weigh up the benefits
of treatment against the possible unwanted effects, before
starting treatment.
• Fluoxetine won’t work straight away. Some people taking
antidepressants feel worse before feeling better. Your doctor
should ask to see you again a couple of weeks after you first
start treatment. Tell your doctor if you haven’t started feeling
better. See section 3,_ How to take Fluoxetine capsules_.
• Fluoxetine is not for use in children and adolescents
under 18. See Section 2,_ Children & adolescents aged 8 to_
_18 years_.
• Some people who are depressed or anxious think of
harming or killing themselves. If you start to feel worse, or
think of harming or killing yourself, see your doctor or go to
a hospital straight away. See Section 2,_ Thoughts of suicide_
_and worsening of your depression or anxiety disorder_.
• Don’t stop taking Fluoxetine without talking to your
doctor. If you stop taking Fluoxetine suddenly or miss a dose,
you may get withdrawal effects. See Section 3,_ If you stop_
_taking Fluoxetine capsules_.
• If you feel restless and feel like you can’t sit or stand still,
tell your doctor. Increasing the dose of fluoxetine may make
these feelings worse. See Section 4,_ Possible side-effects_.
• Taking some other medicines with Fluoxetine can cause
problems. You may need to talk to your doctor. See Section 2,
_Other medicines and Fluoxetine capsules_.
• If you are pregnant or planning to get pregnant, talk to your
doctor. See section 2,_ Pregnancy, breast-feeding and fertility_.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for
you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribe

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluoxetine 10mg hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fluoxetine hydrochloride equivalent to 10mg of
fluoxetine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
The capsules are green opaque and printed ‘C28’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults: _
Major depressive episodes.
Obsessive-compulsive disorder.
Bulimia nervosa: Fluoxetine is indicated as a complement of
psychotherapy for the
reduction of binge-eating and purging activity.
_Children and adolescents aged 8 years and above: _
Moderate to severe major depressive episode if depression is
unresponsive to
psychological therapy after 4–6 sessions. Antidepressant medication
should be
offered to a child or young person with moderate to severe depression
only in
combination with a concurrent psychological therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
_Major depressive episodes:_
Adults and the elderly: The recommended dose is 20 mg daily. Dosage
should be
reviewed and adjusted if necessary within 3 to 4 weeks of initiation
of therapy and
thereafter as judged clinically appropriate. Although there may be an
increased
potential for undesirable effects at higher doses, in some patients,
with insufficient
response to 20 mg, the dose may be increased gradually up to a maximum
of 60 mg
(see section 5.1). Dosage adjustments should be made carefully on an
individual
patient basis, to maintain the patients at the lowest effective dose.
Patients with depression should be treated for a sufficient period of
at least 6 months
to ensure that they are free from symptoms.
_ _
_Obsessive-compulsive disorder:_
Adults and the elderly: The recommended dose is 20 mg daily. Although
there may
be an increased potential for undesirable effects at higher doses, in
some patients, if
after 2 weeks there is insufficient response to 20 mg, the dose may be
increased
gradually up to a maximum of 60 m